Dr. Donald S. Fredrickson 
Page 5 
November 29, 1979 
vessel for inactivation is far superior in terms 
of safety to the concept of allowing a vessel's 
contents to flow into a curbed area followed by 
chemical inactivation. 
p. 12 — VII-C-3-k — Following the word "filter", the 
phrase "or its equivalent, incineration, 
etc." should be inserted. 
Finally, we would like to reiterate some of our concerns 
over the scale-up approval procedures as represented by the 
draft of said procedures dated July 19, 1979, and the discussion 
during the RAC meeting of September 6-7, 1979. 
Our statements are stimulated by an impression that the pro- 
posed procedures do not clearly recognize the need for rapid 
large-scale development not to mention production. We also feel 
that there must be a point after appropriate experience with 
pilot plant and production scale fermentation of K12 organisms 
when these procedures can no longer be considered an experiment. 
In terms of the responsibility of the Director we would like 
to propose that the RAC in accordance with IV-E-l-b-(3)-(d) 
advise the Director that experiments which have a clear 
precedent of prior RAC approval, could be approved by the local 
IBC. Notification of this decision could be made by the local 
IBC to ORDA, the Director and/or a Working Group. In addition, 
we would propose that new experiments at the P2 HVl level or 
below, not involving a request for reduction of containment 
level, would only require local IBC approval. Again, ORDA or a 
Working Group could receive notification of this approval. 
Thus, at these levels and below, a request would not be filed 
with ORDA, but ORDA would receive notification. This notifi- 
cation assumes clear acknowledgment and approval of the 
applicant's laboratory procedures, experience, etc., mentioned 
in 1 e. and f. of the proposed procedures. 
We also believe that once an experiment for more than 10L 
has been approved by the RAC or by the procedures we have just 
outlined, that further expansion in volume be approved by the 
local IBC with notification to ORDA or a Working Group. We* 
feel strongly that if an experiment is safe, risk is not pro- 
portional to the volume because of the safety and reliability 
of the industrial equipment normally used at these levels; but 
if risk exists at all, it is more apt to be proportional to the 
number of times the experiment is done. We would like to 
emphasize that these experiments are not done in Erlenmeyer 
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